Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2011-09-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Molindone
Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion.
Molindone
The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion.
Interventions
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Molindone
The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion.
Eligibility Criteria
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Inclusion Criteria
2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
3. Weight of at least 20kg.
4. Able and willing to swallow tablets whole and not chewed, cut or crushed.
5. Written informed consent/assent obtained from the subject's parent or legally-authorized representative (LAR), and written informed assent obtained from the subject if required.
Exclusion Criteria
2. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
4. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.
6 Years
12 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Dothan, Alabama, United States
Los Angeles, California, United States
Santa Ana, California, United States
Wildomar, California, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Libertyville, Illinois, United States
Indianapolis, Indiana, United States
Terre Haute, Indiana, United States
Owensboro, Kentucky, United States
Toms River, New Jersey, United States
Stony Brook, New York, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Bellevue, Washington, United States
Bothell, Washington, United States
Countries
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Other Identifiers
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810P203
Identifier Type: -
Identifier Source: org_study_id
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